MAUDE Adverse Event Report: RESPIRONICS, INC. REP DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number UDSX700S11F

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation from a user of a dreamstation auto bipap device.The device was set in the cpap mode in error and the user went to the distributor to get the settings changed.The distributor was unable to access the bipap settings to set the machine to the correct pressures.There was no report of patient harm or injury.There was no report of medical intervention.The customer/distributor stated the device will not be returned any time soon.The user feels he/she received the wrong device.The device was replaced for the user with the correct settings.If additional information becomes available or if the device is returned for investigation, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: REP DREAMSTATION AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18623102
• MDR Text Key: 334388737
• Report Number: 2518422-2024-05453
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX700S11F
• Device Catalogue Number: UDSX700S11F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1